Luma supply Fine Tungsten or Tungsten-Rhenium wires for medical applications, e.g.:
Medical applications are ruled by strict specifications and rules to ensure the safety of patients and medical staff. Luma is not manufacturing according to the MDR (Medical Device Regulation), though. It is LUMA customers who are responsible for the function of the devices produced for their applications.
Most of the LUMA wire supplied to the medical industry is Gold plated Tungsten wire. Reason for using Tungsten wire in medical applications are its strength, durability and density. This makes it possible to use very fine dimensions, still trusting the wire to cope with high load. Also, tungsten wire has a very high density, 19.3 g/cm3, which make it highly visible under X-ray. The gold plating serves mainly the purpose to protect the base wire from corrosion.
Tungsten and gold plated Tungsten wires may not stay in the human body for longer than 24 hours, because they are not (yet) classified as biocompatible material. They are only used during the time of a surgery.
Stents
The coronary stents market is most important. Half of the global turnover is created in the Americas. The demand for minimally invasive procedures has been increasing globally.
A stent is a tube which is inserted into for example a body vessel to prevent or counteract a disease-induced localized flow constriction. The term may also refer to a tube used to temporarily hold such a natural conduit open, to allow access for surgery. One gold plated tungsten wire is weaved into the stent for its visibility on x-ray. Due to the high density of tungsten, it is visible on X-ray guides when the medical staffs are placing the stent within the artery.
Guide wire, Catchers and Baskets
Guide wires help to safely access blood vessels or other organs. Gold plated tungsten wire is used as guide wire entering blood vessels or other organs. As the tungsten wire has high density, it is clearly visible on X-ray, guiding medical staff in tight spaces such as obstructed valves or channels when for example inserting and positioning catheters.
A Tungsten wire, often gold plated, can be used as a single wire inserted in a tube OR as a coil around a core, e.g. a large stainless steel inner core.
Baskets and Snatchers for retrieving lost items in the body after a completed surgery. The Snatchers use a single wire. The baskets use a fine woven mesh made of Tungsten wires.
Electro surgery
Electro surgery is a technique applying high-frequency electric current to biological tissue as a mean to cut, coagulate, desiccate or fulgurate tissue. Tungsten wire is used in loop and needle electrodes due to its mechanical properties at high temperature, and its ability to keep its shape and wire integrity throughout an entire surgery.
Proton beam therapy
LUMA gold plated Tungsten or Tungsten-Rhenium wire was used by manufacturers producing instruments for so called proton beam therapy. This technique has proven to be less damaging to healthy tissue when treating cancer tumours. The wire is woven to mesh and put in frames. The equipment uses a similar technology to particle detectors, directing protons to tumours and destroying tumour DNA. Gold plated wire is used to prevent oxidation.
Stimulation therapy, cochlear remediation ( … to stimulate the damaged portions of the inner ear to deliver sound signals to the brain)
Imaging and Whole body scanner devices
… for mesuring structure and consistance of biological matters, e.g. bone structure.
The scanner contains detectors which work with High voltage reflection in natural size X-Ray machines for skeleton surgery. (The principle of detectors is almost the same in many applications, among others particle accelerators in atomic research – a combination of 2 Cathode boards where in the middle a mesh or rows of tungsten wires is installed. Then High Voltage and ground is applied to the Cathode boards which generates a field between the Cathode boards that allows to see particles that pass true the detector).
Surgical enclosure (protection against infection using robot surgery)
Precision medical wires in smart ventilators, advanced remote monitoring systems and deep brain stimulation (DBS)
For the medical industry we mainly supply gold plated round Tungsten wire in the range between 5 and 150 micron (.0002 to .0059”). The thinnest wires are used for research projects .e.g. in DBS (deep brain stimulation) or in DNA denaturation processes. The most wanted diameters are between 50 and 150 micron for the production of Spring coils, guide wires , baskets and snatchers (for retrieving lost items in the body after a completed surgery), or in detectors.
So far all medical applications are for devices that are not made for implantation in the human body because Tungsten is not classified as biocompatible and may not stay in the human body for longer than 24 hours.
DBS: Deep Brain stimulation
This is a Research project together with an international consortium: Analysis of electrical signals in the human brain. Goal: Production of new generation of innovative electrodes based on textile similar technology with the use of conventional polymer and metal materials.
Luma´s part: : Develop and supply Platinum or otherwise plated ultra fine Tungsten Wire which will be delivered to another partner for insulation in polymers. The wires will be implented in the human brain for measuring and detecting misfunctions in the human body BEFORE the outbreak of a disease.
A ”DNA copy machine”
Luma wires are used for the process of denaturation of double DNA strings by heating them up by current to 50-100 degrees Celsius. The aim is to replace the very work intensive traditional Laser technology by heated wires which would be doped with nano particles in a solvent. Simplified this new technique which was developed by a start up enterprise is some kind of DNA copy machine.
Ductility is very important. So the gold plating of the wires has 2 purposes: corrosion protection and ductility.
This treatment is much more accurate than traditional methods cancer healing methods and does not affect surrounding parts of the body. This project for treatment of cancerous tumours is based on the same technology as the particle detectors we are supplying to all around the world. It has a linear accelerator and a synchrotron that accelerate protons up to 60% of the light speed. The particles are then passing through scanning magnets and finally through a scanning and monitoring system. The scanning and monitoring system is 6 wire chambers equiped with 20 and 50 micron tungsten-rhenium-wire in vertical and horizontal direction. The wire is gold plated to secure that it will not oxidize. The accelerated protons are directed to the cancer tumour and destroy its DNA.
Every current impuls provoques a denaturation of the DNA strings and by doing it over and over again and creating copies of copies of copies and so on in the end you would receive a measurable substance. USP characteristic: Proof of infection within minutes instead of days, cheaper and mobile – can be used uncomplicated anywhere in the field.
The technique is in use in over 30 hospitals worldwide, but the status or continuation not confirmed.
Neurosurgery
An US american partner of Luma uses Tungsten and Tungsten-Rhenium wire in the range of approximately 40 microns to make a very small needle used in neurosurgery. It is made into a “needle cartridge” that grabs microscopic electrodes and “sews” them into the cortex. The device will soon be used to help immobile patients better interface with technology.
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Biocompatibility of Tungsten and Molybdenum:
Luma has initiated and completed the first step of a research project about “Biogdegradable Molybdenum and Tungsten medical implants and their possible toxic effects within the human body.”
These are excerpts from the full report, available from Luma, on demand.
Recently, Molybdenum (Mo) and Tungsten (W) have been investigated as potential biodegradable materials. Mo with its moderate degradation rate and advantageous mechanical properties may represent an ideal material for cardiac applications. Tungsten, due to its high density, radiopacity, thrombogenicity and tensile strength has been used in neuroscience and vascular medicine mostly for embolization coils or neural microelectrode probes. Due to an elevated level of tungsten in blood and urine after the implantation of tungsten embolization coils in patients, tungsten was considered to be degradable and investigations on the biological consequences on in-vivo has begun. Little is known about the biocompatibility and long-term outcome of Mo and W implants, and therefore, the present review was performed to evaluate the mechanical performance of metallic Mo and W in vitro and the biodegradation properties in vivo.
Nowadays, biomedical implants are mainly made of metallic materials e.g. Titan or Stainless Steel, but these metal implants have two main problems. The first is the modulus of elasticity, which is higher than the modulus of elasticity of the bone. The second problem is the inability to biodegradability, which leads to inflammation of the surrounding tissue due to the release of cytotoxic ions during the process of implant corrosion.
Fine wires play a critical role in the design of many medical devices such as stents, guide wires, catheters, pacemakers, clips, functional electrical stimulation systems or orthodontic braces with diameters ranging from 10-100 microns. Mo and W have been considered as suitable candidates of transient electronic devices due to their mechanical, electrical, biocompatible properties as well as their predictable and controllable dissolution mechanisms in biofluids.
The performance criteria of an ideal biodegradable metal material (BMM) device should match the injured tissue reconstruction process and provide a temporary mechanical support and completely dissolve in longer time frames with an appropriate degradation rate tolerable for the human body.
BMMs must possess optimal mechanical properties such as strength, ductility and a degradation rate <0.5 mm/ year in simulated body solution at 37 °C. A higher ductility (> 20%) and a moderate resistance value are desirable for cardiovascular stents.
Molybdenum is an essential mineral in the human body. The kidneys are the main regulators of molybdenum levels in the body and are responsible for its excretion. Mo is stored in the liver, kidney, adrenal glands, and bone. The biocompatibility of Mo is more accepted by scientist than for W. Tungsten has no essential role in the human body although it has a long implant history because of it´s enhanced physical qualities.
One very critical use for fine wire are ventilators which contain sensors which rely on fine wire to operate and help patients to breathe properly on their own. Guide wires are integral to ultrasound imaging systems, stents, intracardiac ablation and mapping catheters, pacemakers, endoscopic therapeutic devices, treatment devices for cerebral vascular disease or very thin orthodontic braces.
Biodegradable stents may prevent metallic stent complications such as in-stent restenosis, late cardiovascular thrombosis or chronic inflammation since its service lifetime is approximately 2 years and therefore have great potential for the treatment of artery disease. In the first 4 months is expected a very slow degeneration so that a mechanical support could be provided to the vessels.
Corrosion rates for W and Mo are low, but in the right order of magnitude for small bioresorbable implants like stents.
Rising cost of Raw materials:
In general there is a clear tendency of rising cost of raw materials. The raw materials used in the production of fine medical wire include Tungsten, Silver, Gold, Platinum, Tantalum, Stainless steel of different qualities, Nitinol (a Nickel-Titanium Alloy), Beryllium, and others.
Allover Alloys dominate in materials for the medical sector. Luma work mainly with Tungsten or Tungsten-Rhenium (97/3) in the medical field, mostly plated with gold, and we offer plating services for other kind of base materials, among them SS or silver wires which need to be goldplated sometimes in order to make them visible under X-Ray, or protect against corrosion.
It will be more difficult to use some of the current rare materials in future as the BOMcheck listing including ROHs and REACH lists more critical substances every year which are menaced by explotation.
BOMcheck: Synchronized Material Declaration System
ROHs: Restriction of Certain Hazardous Substances
REACH: Registration, Evaluation, Authorisation and Restriction of Chemicals)
The rising potential of artificial intelligence/machine learning (AI/ML) based software as a medical device
Global fine medical wires market growth can be attributed to the major technological innovations among others. As per the FDA paper published in 2019, Artificial intelligence (AI) and machining learning (ML) are rapidly being used in many industries of Industry 4.0, including the healthcare industry. AI and machine learning (ML) can be used to deliver useful guidance and enhance the production of medical technologies, as well as transform the way patient data is collected and analyzed, both for the advantage of the patient and potential medical studies.
Information gathering is the backbone of AI and ML, and none is feasible without consistently recorded, valuable information. This need for information collection has exerted importance on medical device manufacturers to build and improve systems that offer constant updates on the patient’s health and medical device’s status. In AI and ML medical devices, another critical component is the medical wire. Medical wire is in charge of detecting and communicating information inside the human body.
The processing and eventual delivery of critical data are not feasible without a medical wire module that has been configured to perform properly with the system, whether it is glucose testing or heart rate monitoring. Medical devices require optimized fine medical wire for such automatic notifications and data processing to be efficient. Thus, many manufactures are now attempting to integrate a wide range of advanced technological features into these structural wire-based products which are anticipated to further creates the prospects for the next evolution. In which the fine medical wire will become smart due to sensory type-based device.
Leading markets for fine medical wires:
Biggest market: North America (40+%), followed by Europe (30% )
Biggest growth area: Asia Pacific
In Europe Germany is emerging as a leader in the fine medical wire, followed by the UK and France
Germany accounts for a significant portion of global medicinal technology demand and is the third biggest of the world manufacturing countries. Because of cooperation between researchers and practitioners, Germany’s medicinal technology sector has emerged as a global benchmark for efficiency, quality, and health standards.
Luma is certified according to ISO 9001 industry and 14001 environmental standard. Plus ISO 45001:2018 which concerns the general Working Place environment according to Swedish law.
We have started the process of working actively with the european AGENDA 2030 which is part of the European sustainability policy and includes 17 different domains for sustainability on all levels.
Luma does NOT work according to medical standard requirements. It is our customers who have to fulfil them. Same is valid, for instance, for all customers who work according to automotive standards. For them Luma is a supplier of semi-finished products which would be built into their devices for which them have the responsibility of qualifying, not Luma.
In production we follow up processes by SPC (Statistical process control), if required and specified and by frequent testing which is documented. We use front end technology like Scanning electron microscopy (SEM) and Atomic Absorption Spectroscopy (AAS) to ensure the consistent quality of our base wires and the coatings.
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